Label: OUTBACK 2 IN 1 PROTECTION- octinoxate,avobenzone and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 16, 2015

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  • Active Ingredients

    OCTINOXATE : 7.5 % AVOBENZONE : 1.3% ZINC OXIDE :9.5%

  • Inactives

    TEA TREE OIL

    EUCALYPTUS POLYBRACTEA LEAF OIL

    CITRONELLA OIL

    LEPTOSPERMUM PETERSONII LEAF OIL

    VANILLA

    ACTILASTIN 1000

  • Purpose

    Sunscreen, helps prevent sunburn.

  • Directions of Usage

    Apply liberally 15 minutes before sun exposure, reapply after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours.

  • Warnings

    For external use only.

    When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if a rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact the Poison Control Center  immediately.

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of  15 or higher and other sun protection measures including: limit time in the sun, especially between 10 a.m – 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor

  • Product Label

    sunscreen

  • INGREDIENTS AND APPEARANCE
    OUTBACK 2 IN 1 PROTECTION 
    octinoxate,avobenzone and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69594-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE13 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION95 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69594-005-0175 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/16/2015
    Labeler - Ultra Mix (Aust) Pty Ltd (752254649)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Mix (Aust) Pty Ltd752254649manufacture(69594-005) , label(69594-005)
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